MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 31/33; HEART VALVE MECHANICAL

Model Number ONXM-31/33

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Organ Dehiscence (2502); No Information (3190)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

On-x prosthetic heart valve onxm-31/33, sn (b)(4), implanted (b)(6) 2017 was replaced with onxm-27-29, sn (b)(4) (b)(6) 2017.Reason for replacement/explant is unknown at this time.

Manufacturer Narrative

According to additional information, reoperation of the mitral valve was due to recurrent prosthetic endocarditis and partial dehiscence of the mitral valve.The patient is currently hospitalized as of (b)(6) 2017 for multiple medical issues including diabetes.A hand surgeon is being consulted and the patient is on dialysis.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

On-x prosthetic heart valve onxm-31/33, sn (b)(4), implanted (b)(6) 2017 was replaced with onxm-27-29, sn (b)(4), (b)(6) 2017.

Manufacturer Narrative

The manufacturing records for the onxm-31/33 sn (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.The onxm-31/33 sn (b)(4) was reported as implanted (b)(6) 2017 in the mitral positions as part of a double-valve case (with onxace-21 sn (b)(4) in the aortic position) of a (b)(6) male.Implant registration cards suggest this mitral valve was explanted and replaced on (b)(6) 2017 with onxm-31/33 sn (b)(4) (146 days postop).Follow-up information reports the re-operation was due to recurrent heart valve endocarditis and partial dehiscence of the mitral valve.The patient has multiple medical issues including diabetes for which he is on dialysis.This is a probable paravalvular leak (pvl) due to infection compromising the integrity of the tissue anchoring the valve in place.The location of the pvl was not identified.Because the aortic and mitral valves are in close proximity to each other, the leak could be in the interstitial space between them.But we do not know the status of the aortic valve, only the mitral.In any case, without sufficient annular integrity, the valve cuff can separate (i.E.Dehisce) from the annulus breaking the seal and creating a leak around the periphery thereby decreasing the effectiveness of valve function, whether mitral or aortic.Pvl is an uncommon but recognized risk of mitral valve replacement surgery, as is explantation.Both are listed as potential complications in the on-x valve instructions for use.Objective performance criterion report a rate of all pvl of 1.2 %/patient-year and major pvl of 0.6%/patient-year [iso 5840:2005].In clinical trials, late (>30 days) occurrences of 1 major and 2 minor pvls were observed in a study of 142 mitral on-x patients [mcnicholas 2006).Another study of 117 mitral on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007).Root cause for this event is unknown, however, based on available information, a probable paravalvular leak as a consequence of infection (endocarditis) that deteriorated the integrity of the surrounding annular tissue compromising the seal between the valve and annulus could be the cause.No further action is required at this time.

Event Description

On-x prosthetic heart valve onxm-31/33, sn (b)(4), implanted (b)(6) 2017 was replaced with onxm-27-29, sn (b)(4) (b)(6) 2017.

• Brand Name: ONX MITRAL STANDARD 31/33
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 7133637
• MDR Text Key: 95383875
• Report Number: 1649833-2017-00091
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/22/2017
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 11/22/2017; 11/22/2017
• Supplement Dates FDA Received: 12/20/2017; 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 42 YR